Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT04812067
Eligibility Criteria:
Inclusion Criteria:
* Male or female, 18 years of age or older
* Subjects who are women of childbearing potential (WOCBP) must be using an acceptable method of birth control (See Section 6.4.3)
* Proposed Study Eye that has been diagnosed with an ocular condition that, in the opinion of the Investigator, could possibly benefit from TTHX1114 administration, and has a measurable efficacy endpoint
* Fellow Eye with 20/100 BCVA or better
* No concurrent ocular or medical condition that would impair the assessment of safety and efficacy
Exclusion Criteria:
* Prior exposure to TTHX1114
* Intolerance, hypersensitivity, or significant allergy to any drug compound, food, or other substance (Note: This includes all components and excipients of the study drug)
* Current or recent (e.g., the 28 days prior to Study Day 0) participation in any other, interventional clinical research study
* History of:
* Ocular cancer (including melanoma)
* Herpetic keratitis
* Documented and repeated elevated IOP in either eye
* Posterior Polymorphous Corneal Dystrophy (PPCD; aka Schlichting dystrophy)
* Uveitis
* Use of any concomitant medications that may interfere with the assessment of safety and efficacy
* Any other reason (e.g., serious systemic disease or uncontrolled medical condition) that, in the opinion of the Investigator could increase the subject's risk, interfere with the interpretation of the study results, or affect the subject's ability to provide informed consent or comply with the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04812067
Study Brief:
Protocol Section:
NCT04812067